Regulatory Affairs Manager Dentsply SironaRegulatory Affairs ManagerSan Jose, CAThis role works closely with business partners for registrations in their respective countries to ensure compliance globally and acts as an internal champion for initiatives aimed at improving business systems and compliance. • Manages day-to-day activities for less senior Regulatory Affairs professionals, including but not limited to mentoring, coaching, performance reviews, developmental plans, and succession planning.
NewSr. Regulatory Affairs - Contract TalentBurst, Inc.Sr. Regulatory Affairs - ContractSunnyvale, CAStrong verbal and written communication skills, proven ability to translate technical documentation into effective internal documentation, and regulatory submissions. Provide regulatory guidance to product teams, develop regulatory plans, and review and approve product design control documentation.
NewRegulatory Affairs Specialist IV JouléRegulatory Affairs Specialist IVMountain View, CA$60 / hourMinimum 8 years of regulatory affairs experience working in a medical device company (can be in combination with a regulatory affairs master degree; e.g., Masters in Regulatory Science). • Strong verbal and written communication skills, proven ability to translate technical documentation into effective internal documentation and regulatory submissions.
Associate Director, State Government Affairs - Remote Agios PharmaceuticalsAssociate Director, State Government Affairs - RemoteSan Jose, CARemote$153,541–$230,312 / yearThe current base salary range for this position is expected to be between $153,541 and $230,312 annualized; final salary will be determined based on various factors including, but not limited to, years of relevant experience, job knowledge, skills and proficiency, degree/education, and internal comparators. Our team’s proven track record of executional excellence, combined with our depth of expertise and dedication, enables us to develop innovative medicines that reflect the priorities of rare disease communities.
Senior Manager, Medical Affairs Operations - Remote Agios PharmaceuticalsSenior Manager, Medical Affairs Operations - RemoteSan Jose, CARemote$131,035–$196,553 / yearManage the execution of Agios’ patient advocacy conference plans for PK deficiency, thalassemia, and sickle cell disease; participate in cross-functional planning meetings; obtain compliance approval for related materials; and attend virtual and in-person conferences, when needed. Provide operational and project management support to the US patient advocacy team, ensuring smooth day-to-day coordination across priorities, stakeholders, and deliverables, and flex to support various other functions within Medical Affairs as needs arise.
Director, Regulatory Strategy (Pediatrics) - Remote Agios PharmaceuticalsDirector, Regulatory Strategy (Pediatrics) - RemoteSan Jose, CARemote$183,549–$275,324 / yearThe current base salary range for this position is expected to be between $183,549 and $275,324 annualized; final salary will be determined based on various factors including, but not limited to, years of relevant experience, job knowledge, skills and proficiency, degree/education, and internal comparators. This individual will lead cross-functional teams in preparing and overseeing development of compliant, high quality, nonclinical and clinical global regulatory submissions to support development, registration, or life cycle management activities.
NewSenior Director/Executive Director, Scientific Communications Coherus BioSciencesSenior Director/Executive Director, Scientific CommunicationsRedwood City, CA$230,000–$290,000 / yearThis highly visible role will partner closely with Medical Affairs, Clinical Development, Translational Medicine, Biostatistics, Regulatory Affairs, Legal, Compliance, Commercial, and Executive Leadership to develop and maintain a compelling scientific narrative across all stages of product development. The Senior Director/Executive Director will lead publication strategy and execution, scientific platform development, congress communications, and field medical content development while ensuring alignment with broader Medical Affairs, Clinical Development, and corporate objectives.
NewSenior Director, Pricing, Contracting & Government Programs Coherus BioSciencesSenior Director, Pricing, Contracting & Government ProgramsRedwood City, CA$230,000–$260,000 / yearThis role provides end-to-end leadership across Commercial Pricing & Contracting and U.S. Government Programs, ensuring commercially competitive, operationally feasible, and fully compliant pricing, contracting, and rebate execution. The position oversees commercial contract strategy and execution, government price reporting, rebate processing, and state price transparency, and partners closely with Market Access, Finance, Legal, Compliance, Trade, Analytics, and external vendors.
NewDirector, Clinical Quality Assurance (CQA) Coherus BioSciencesDirector, Clinical Quality Assurance (CQA)Redwood City, CA$190,000–$240,000 / yearThe position will also be responsible for supporting and hosting regulatory inspections and defining and implementing clinical compliance plans to include GCP/GCLP/GVP audits of service providers, CROs, investigator sites, bioanalytical laboratories, and Drug Safety and Pharmacovigilance systems and processes. This role is responsible for ensuring that Coherus plans and systems that govern clinical studies are in compliance with regulatory requirements, industry best practices (ie GCP, GLP, GVP) and company SOPs by working with Quality management, external auditors, and other internal Clinical functions.
Associate Director/ Director, Patient Marketing - Remote Agios PharmaceuticalsAssociate Director/ Director, Patient Marketing - RemoteSan Jose, CARemote$183,549–$275,324 / yearThe current base salary range for this position at the Associate Director level is expected to be between $153,541 and $230,312 annualized and the current base salary range for this position at the Director level is expected to be between $183,549 and $275,324 annualized; final salary will be determined based on various factors including, but not limited to, years of relevant experience, job knowledge, skills and proficiency, degree/education, and internal comparators. The Associate Director/Director, Patient Marketing will focus on developing and executing the patient strategy in preparation for the future launch of mitapivat, currently in development for sickle cell disease, a vastly underserved community.
NewClinical Supplies Specialist I JouléClinical Supplies Specialist IAlameda, CA$27–$32 / hourBS/BA degree in a related discipline with at least three years of related experience, or MS/MA degree with at least one year of related experience, or an equivalent combination of education and experience. Prepare packaging and labeling requests, manage depot and site shipments, and monitor study drug inventory levels.
Associate Director, Scientific Communications & Publications - Remote Agios PharmaceuticalsAssociate Director, Scientific Communications & Publications - RemoteSan Jose, CARemote$153,000–$230,000 / yearOperating at the intersection of strategy and execution, this role partners closely with cross-functional colleagues and external experts to deliver high‑impact publications and scientific communications that advance both patient care and scientific dialogue. The current base salary range for this position is expected to be between $153,000 and $230,000 annualized; final salary will be determined based on various factors including, but not limited to, years of relevant experience, job knowledge, skills and proficiency, degree/education, and internal comparators.
Medical Director, Sickle Cell Disease, Clinical Development Agios PharmaceuticalsMedical Director, Sickle Cell Disease, Clinical DevelopmentSan Jose, CA$221,600–$369,333 / yearThe current base salary range for this position is expected to be between $221,600 and $369,333 annualized; final salary will be determined based on various factors including, but not limited to, years of relevant experience, job knowledge, skills and proficiency, degree/education, and internal comparators. Follow important developments and relevant trends in scientific literature and develop/maintain contracts with external experts to support understanding of the candidate drug effects and to gain strategic insights to the further development and placement of study and overall program.
Senior Director, Clinical Education and Events Dentsply SironaSenior Director, Clinical Education and EventsSan Jose, CAThis leader serves as the senior clinical authority for NAM education, ensuring programs meet the needs of practicing clinicians while supporting business priorities, product adoption, and long term customer trust. • Oversee planning and execution of clinical educational events (e.g., courses, workshops, symposia, webinars), ensuring end-to-end operational excellence (logistics, faculty coordination, attendee experience) and alignment to learning objectives.
NewRegional Director - Anesthesiology - Vituity Practice Management - Emeryville VituityRegional Director - Anesthesiology - Vituity Practice Management - EmeryvilleEmeryville, CACommit to creating and demonstrating inclusivity within Vituity including codesigning, building, and executing strategies, policies, and practices that cultivate equity, inclusion, and fair opportunity for all; demonstrating preparedness to educate, mitigate, coach, and address daily bias and exclusion in partnership with the site leadership. Accountable for ensuring meaningful integration occurs: Identify opportunities for practice line integration to ensure the quality and efficiency of patient care delivery across the acute care continuum; assist with new service line startups; engage regularly with integrated site RDs.
Regulatory Affairs Associate Jess BusheyRegulatory Affairs AssociateMountain View, California$75,000–$95,000Coordinate and maintain regulatory documentation, including preparation for local and regional registrations, license renewals, and product submissions. This role is pivotal in ensuring compliance with various global regulations, including FDA 21 CFR 820, EN ISO 13485, and the European Medical Regulation (MDR).
Strategy and Operations Lead, Regulatory Affairs Google LLCStrategy and Operations Lead, Regulatory AffairsCAYou will also partner with teams across Google and Alphabet's Public Policy, Compliance, Legal, Engineering, Finance and product areas to support the handling of some of the most important issues for the company today. In this role, you will work closely with members of Regulatory Affairs and act as the central operations support for the department"s role in the broader regulatory lifecycle.
NewRegulatory Affairs Associate Heluna HealthRegulatory Affairs AssociateSan Francisco, CaliforniaUnder the direction of Susan Buchbinder, MD, Bridge HIV has been conducting HIV and STI preventive vaccine studies, HIV pre-exposure prophylaxis (PrEP) studies (including oral and injectable medications), and other studies of biomedical HIV prevention strategies since the early days of the epidemic. The Bridge HIV Investigators are global leaders in HIV vaccine and prevention science, epidemiology of HIV infection, HIV medication adherence, combination HIV prevention strategies, and HIV research training methods.
Associate Director, Regulatory Affairs Advertising and Promotion Mirum PharmaceuticalsAssociate Director, Regulatory Affairs Advertising and PromotionFoster City, CaliforniaManage and author commercial regulatory submissions, working closely with the Publishing vendor to ensure timely publishing and submission of promotional materials to the Office of Prescription Drug Promotion (OPDP). Bachelor’s or advanced degree in a scientific discipline, with a minimum of 8 years in Regulatory Affairs with a minimum of 6 years of experience in the regulatory review of advertising and promotional materials for prescription drug and/or biologic products.
NewAssociate Director, Global Regulatory Affairs Clinical Strategy - Job ID: 1998 Ascendis PharmaAssociate Director, Global Regulatory Affairs Clinical Strategy - Job ID: 1998Palo Alto, CA$185,000–$205,000Contributes to the development of global clinical and regulatory plans and strategies, identifies and proposes risk mitigation strategies, and influences project teams and sub teams across international site locations. Do you want to be part of building a fully integrated biopharmaceutical company together with a team of highly skilled colleagues who are passionate about developing best-in-class therapeutics that address significant unmet medical needs?
Associate Director, Regulatory Affairs Strategy, Hematology Oncology Nurix Therapeutics IncAssociate Director, Regulatory Affairs Strategy, Hematology OncologyBrisbane, CAThe successful candidate will be a core member of the Regulatory team and will be responsible for helping build and execute on global regulatory strategy, objectives, policies and programs pertaining to development and future marketing of products for guiding and executing upon regulatory strategy of compliant, high quality, nonclinical and clinical submissions and interactions in support of early development, registration and life cycle management activities. Works strategically with all regulatory functions to develop detailed, actionable submission plans, tracks major submission deliverables, and ensures consistent management submission documents, health authority communications, and all other regulatory information supporting Nurix's investigational and marketing applications.
Regulatory Affairs Associate (Principal) - Medical Devices Apple IncRegulatory Affairs Associate (Principal) - Medical DevicesCupertino, CAThis role will involve assessment of regulatory impact for new and modified Class I, II and III products, including identification of assumptions/risks/mitigations to develop and execute clear regulatory plans in the US and globally. You will represent the RA/QA team on a diverse array of regulatory initiative teams and new product development, with the goal of obtaining approvals for new technologies.
Director, Regulatory Affairs Nova Pneuma IncDirector, Regulatory AffairsFremont, CAManage and prepare post-market filings and product safety reports (e.g., Annual Reports, DSUR, PSUR, REMS Annual Report, Supplements, Technical Documentation File lifecycle maintenance, responses to regulatory information requests). Experience with commercial products, Drug Safety/ Pharmacovigilance (adverse event reporting, DSUR, PSUR, REMS Annual Reports and audits), product approval process, and post-market surveillance.
Associate Director, Regulatory Affairs Advertising and Promotion Mirum Pharmaceuticals IncAssociate Director, Regulatory Affairs Advertising and PromotionFoster City, CA$205,000–$225,000 / yearEducation /Experience: Bachelor's or advanced degree in a scientific discipline, with a minimum of 8 years in Regulatory Affairs with a minimum of 6 years of experience in the regulatory review of advertising and promotional materials for prescription drug and/or biologic products. Manage and author commercial regulatory submissions, working closely with the Publishing vendor to ensure timely publishing and submission of promotional materials to the Office of Prescription Drug Promotion (OPDP).
Director, Regulatory Affairs Nurix Therapeutics IncDirector, Regulatory AffairsBrisbane, CAThis role will be responsible for developing the global regulatory strategy in collaboration with key internal stakeholders, as well as tactical implementation of that strategy guiding and executing compliant, high quality, nonclinical and clinical submissions and interactions in support of early development, registration and life cycle management activities. Works strategically with all regulatory functions to develop detailed, actionable submission plans, tracks major submission deliverables, and ensures consistent management submission documents, health authority communications, and all other regulatory information supporting Nurix's investigational and marketing applications.
Manager, Regulatory Affairs iRhythm Holdings IncManager, Regulatory AffairsSan Francisco, CARemote$127,000–$165,000 / yearLead FDA submissions (510(k) or pre-submissions) with the team, including wearable devices, as well as artificial intelligence (AI) Software as a Medical Device (SaMD) products. There have been instances where individuals not associated with iRhythm have impersonated iRhythm employees pretending to be involved in the iRhythm recruiting process, or created postings for positions that do not exist.
Senior Regulatory Affairs Director - Oncology Cell & Gene Therapy AstraZeneca PlcSenior Regulatory Affairs Director - Oncology Cell & Gene TherapySouth San Francisco, CA$218,058.40–$327,087.60 / yearWorking with colleagues across locations, therapy areas and external partners, this role offers the chance to influence strategy end-to-end, from early development through rapid global approvals, while learning from leading experts, sharing best practices and using data, technology and modern approaches to reduce barriers for patients worldwide. Competitive salary and benefits package on offer: Recognizing the importance of individualized flexibility, our ways of working allow employees to balance personal and work commitments while ensuring we continue to create a strong culture of collaboration and teamwork by engaging face-to-face in our offices 3 days a week.
NewSr Manager/Assoc Director, CMC Regulatory Affairs ErascaSr Manager/Assoc Director, CMC Regulatory AffairsSouth San Francisco, CAAssess proposed CMC changes (e.g., manufacturing processes, analytical methods, specifications, manufacturing sites, container closure systems, stability programs, and suppliers) and support development of appropriate global regulatory filing strategies. Deliver CMC regulatory support through QC review of submission components, including CMC documents, labeling, application forms, supporting GMP documentation, cover letters and verification of submission links, ensuring completeness, consistency, and compliance with regulatory requirements.
Manager, Regulatory Affairs iRhythmManager, Regulatory AffairsSan Francisco, CaliforniaRemoteLead FDA submissions (510(k) or pre-submissions) with the team, including wearable devices, as well as artificial intelligence (AI) Software as a Medical Device (SaMD) products. There have been instances where individuals not associated with iRhythm have impersonated iRhythm employees pretending to be involved in the iRhythm recruiting process, or created postings for positions that do not exist.
Associate Director, Regulatory Affairs Project Planning & Coordination Acadia Pharmaceuticals IncAssociate Director, Regulatory Affairs Project Planning & CoordinationSan Francisco, CA$154,000–$193,000 / yearWe are developing the next wave of therapeutic advancements with a robust and diverse pipeline that includes mid- to late-stage programs in Alzheimer's disease psychosis and Lewy body dementia psychosis, along with earlier-stage programs that address other underserved patient needs. The Associate Director, Regulatory Affairs Project Planning & Coordination is responsible for developing, implementing, and monitoring project plans and best practices that facilitate how the Global Regulatory Affairs department executes its strategic and functional goals.
Associate Director, Regulatory Affairs CMC Iovance Biotherapeutics IncAssociate Director, Regulatory Affairs CMCSan Carlos, CARemote$140,000–$160,000 / yearMental: Clear and conceptual thinking ability; excellent judgment, troubleshooting, problem-solving, analysis, and discretion; ability to handle work-related stress; ability to handle multiple priorities simultaneously; and ability to meet deadlines. Organizational and planning skills; ability to influence and negotiate professionally at various levels within the project team and with external partners while maintaining positive working relationships.
Sr. Manager/Associate Director, Regulatory Affairs Oruka Therapeutics IncSr. Manager/Associate Director, Regulatory AffairsMenlo Park, CA$161,000–$187,000 / yearOruka's mission is to offer patients suffering from chronic skin diseases like plaque psoriasis the greatest possible freedom from their condition by achieving high rates of complete disease clearance with dosing as infrequently as once or twice per year. This individual will work closely with cross-functional teams to provide regulatory guidance throughout product development, support health authority interactions, and help ensure the timely preparation and submission of high-quality regulatory applications.
Regulatory Affairs Quality/Standards/Training Manager - Remote Roth Staffing CompaniesRegulatory Affairs Quality/Standards/Training Manager - RemoteAlameda, CaliforniaRemote$85–$93.68 / hourCollaborate with Quality Assurance and cross‑functional stakeholders to support health authority inspections across GPS and Regulatory Affairs, ensuring the RA function remains in a continuous state of inspection readiness. · Work with Regulatory Affairs Strategist, CRO and Clinical Operations to ensure the Trial Master File (TMF) and Veeva RIM is kept current and complete for Regulatory Affairs-related documents.
Executive Director, Regulatory Affairs CMC AllakosExecutive Director, Regulatory Affairs CMCRedwood City, CaliforniaLeads the development of strategic CMC plans and tactical implementation for the creation and submission of Regulatory documents, e.g., INDs, BLAs, CTAs, MAAs, and other relevant regulatory filings. Exec Director Regulatory Affairs/CMC Allakos Inc. is a dynamic clinical-stage biopharmaceutical company developing first-in-class antibody-based therapeutics to treat allergic and inflammatory diseases.
Senior Director, Regulatory Affairs Policy, Regulatory Intelligence & Compliance Exelixis IncSenior Director, Regulatory Affairs Policy, Regulatory Intelligence & ComplianceAlameda, CAThe position oversees the surveillance, triage, interpretation, and dissemination of global regulatory intelligence across Research & Development (R&D), Quality (QA), Information Technology (IT) and Pharmaceutical Supply Chain (PSC), partnering with cross-functional subject matter experts to ensure impact assessments are conducted and documented. EDUCATION/EXPERIENCE/KNOWLEDGE & SKILLS: Education: BA/BA degree in related discipline and 15 years of related experience; or, MA/MA degree in related discipline and 13 years of related experience; or, PhD in related discipline and 12 years of related experience; or, Equivalent combination of education and experience.
Associate Director, Regulatory Affairs CytokineticsAssociate Director, Regulatory AffairsSouth San Francisco, CaliforniaCytokinetics is a specialty cardiovascular biopharmaceutical company, building on its over 25 years of pioneering scientific innovations in muscle biology, and advancing a pipeline of potential new medicines for patients suffering from diseases of cardiac muscle dysfunction. Reporting to the Executive Director, Regulatory Affairs, the Associate Director, Regulatory Affairs, is responsible for hands-on regulatory activities across development stages, ensuring high-quality submissions and effective interactions with health authorities.
Associate Director, Global Regulatory Affairs Project Management Revolution MedicinesAssociate Director, Global Regulatory Affairs Project ManagementRedwood City, CaliforniaDrive the operational planning, coordination, and tracking of new drug marketing application submission activities across cross-functional Filing Teams (including Regulatory, Medical Writing, Nonclinical, Clinical, Safety, Biostatistics, CMC / Pharmaceutical Development and Manufacturing, etc. and external consultants), supporting the Global Filing Lead’s strategic vision. The company’s RAS(ON) inhibitors daraxonrasib (RMC-6236), a RAS(ON) multi-selective inhibitor; elironrasib (RMC-6291), a RAS(ON) G12C-selective inhibitor; zoldonrasib (RMC-9805), a RAS(ON) G12D-selective inhibitor; and RMC-5127, a RAS(ON) G12V-selective inhibitor, are currently in clinical development.
Associate Director, Global Regulatory Affairs Project Management Revolution Medicines IncAssociate Director, Global Regulatory Affairs Project ManagementRedwood City, CA$186,000–$233,000 / yearDrive the operational planning, coordination, and tracking of new drug marketing application submission activities across cross-functional Filing Teams (including Regulatory, Medical Writing, Nonclinical, Clinical, Safety, Biostatistics, CMC / Pharmaceutical Development and Manufacturing, etc. and external consultants), supporting the Global Filing Lead's strategic vision. The company's RAS(ON) inhibitors daraxonrasib (RMC-6236), a RAS(ON) multi-selective inhibitor; elironrasib (RMC-6291), a RAS(ON) G12C-selective inhibitor; zoldonrasib (RMC-9805), a RAS(ON) G12D-selective inhibitor; and RMC-5127, a RAS(ON) G12V-selective inhibitor, are currently in clinical development.
Associate Regulatory Affairs Strategy Director (Oncology) Exelixis IncAssociate Regulatory Affairs Strategy Director (Oncology)Alameda, CA$195,000–$277,500 / yearEDUCATION/EXPERIENCE/KNOWLEDGE & SKILLS: Education/Experience: Bachelor's degree in related discipline and a minimum of eleven years of related experience; or, Master's degree in related discipline and a minimum of nine years of related experience; or, PhD degree in related discipline and a minimum of five years of related experience; or, Equivalent combination of education and experience. Experience/The Ideal for Successful Entry into Job: Knowledge/Skills: Develops and manages plans within established timelines and balances commitments to complete multiple activities and achieve results.
NewDirector Regulatory Affairs - Oncology Early Development AbbVie IncDirector Regulatory Affairs - Oncology Early DevelopmentSouth San Francisco, CAMore than 1,000 AbbVie scientists, clinicians, and product developers with strong entrepreneurial roots work to combine their expertise in immuno-oncology, stem cells, and cell-signaling with their knowledge of bispecific antibodies, antibody-drug conjugates (ADCs), and covalent-inhibitor technologies to discover and develop novel cancer treatments. The Director Regulatory Affairs Global Regulatory Lead in OED RA is responsible for developing and implementing global regulatory strategies to support the development of multiple oncology early development assets, contributing to the advancement of leading-edge cancer research in a nimble, biotech -like environment within a large, well established pharmaceutical company.
Regulatory Affairs Specialist - Vascular (on-site) Abbott LaboratoriesRegulatory Affairs Specialist - Vascular (on-site)Santa Clara, CA$81,500–$141,300 / yearOur extensive portfolio includes drug-eluting stents, bare metal stents, guide wires, balloon dilatation catheters, imaging catheters and software, vessel closure devices and peripheral stents. The ideal candidate will possess strong analytical and project management skills, a working knowledge of medical device regulations, and the ability to interpret complex regulatory requirements and apply them to product development and lifecycle management activities.
Vice President, Regulatory and Head of Regulatory Affairs Sagimet Biosciences IncVice President, Regulatory and Head of Regulatory AffairsSan Mateo, CA$340,000–$370,000 / yearThis role will serve as the primary liaison with global regulatory authorities and involve close collaboration with Sagimets cross-functional teams and external partners, to ensure the successful advancement of our clinical programs. Oversee the companys external regulatory advisors, consultants and vendors to ensure that relevant regulatory advice is provided with respect to the companys development programs.
Regulatory Affairs Program Manager - Pleasanton, CA CalyxoRegulatory Affairs Program Manager - Pleasanton, CAPleasanton, CA$160,000–$175,000 / yearAs a senior member of the Calyxo Regulatory Team, you will work closely with Research & Development, Operations, Quality, Clinical and Medical Affairs, Marketing, and Legal to ensure regulatory alignment from concept through commercialization—balancing speed with compliance as we bring category-defining medical devices to market. Lead the strategy, preparation, submission, and negotiation of complex U.S. and international regulatory filings (including 510(k)s, Q-Subs/Pre-Submissions, Special 510(k)s, and Letters to File), ensuring timely approvals and serving as the technical lead on the most challenging submissions.
Associate Director, Regulatory Affairs Iovance Biotherapeutics IncAssociate Director, Regulatory AffairsSan Carlos, CARemote$170,000–$200,000 / yearCollaborates closely with functional leaders to 1) create the optimal development path for Iovance product candidates, 2) negotiate optimal development paths within cross-functional teams and with health authorities, 3) execute clinical-regulatory development plans on-time and while managing all identified risks. Mental: Clear and conceptual thinking ability; excellent judgment, troubleshooting, problem-solving, analysis, and discretion; ability to manage work-related stress; ability to manage multiple priorities simultaneously; and ability to meet deadlines.
Director/Senior Director, Regulatory Affairs SepternaDirector/Senior Director, Regulatory AffairsSouth San Francisco, CA$235,000–$285,000 / yearSepterna is a biotechnology company based in South San Francisco, CA on a mission to develop life-changing medicines for patients with the vision to become the industry-leading G protein-coupled receptor (GPCR)-focused drug discovery company. To join our ambitious team, be prepared to bring your real self to work every day; grow and learn from a talented team of drug hunters, scientists, and business professionals; and contribute your passion, creativity, and energy to accomplish our mission.
Director, Regulatory Affairs Nova Pneuma, Inc.Director, Regulatory AffairsFremont, CAPart timeManage and prepare post-market filings and product safety reports (e.g., Annual Reports, DSUR, PSUR, REMS Annual Report, Supplements, Technical Documentation File lifecycle maintenance, responses to regulatory information requests). Experience with commercial products, Drug Safety/ Pharmacovigilance (adverse event reporting, DSUR, PSUR, REMS Annual Reports and audits), product approval process, and post-market surveillance.
Associate Director, Regulatory Affairs (on-site) Abbott LaboratoriesAssociate Director, Regulatory Affairs (on-site)Alameda, CA$148,700–$297,300 / yearThe individual will play a critical role in anticipating and influencing evolving regulations and guidance, lead complex management change initiatives, interface with outside regulatory agencies and trade associations, and advise executive management with strategic insights and key regulatory metrics. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines.
Associate Director, Regulatory Affairs (on-site) AbbottAssociate Director, Regulatory Affairs (on-site)Alameda, CaliforniaThe individual will play a critical role in anticipating and influencing evolving regulations and guidance, lead complex management change initiatives, interface with outside regulatory agencies and trade associations, and advise executive management with strategic insights and key regulatory metrics. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines.
Principal Regulatory Affairs Specialist Procept Biorobotics CorpPrincipal Regulatory Affairs SpecialistSan Jose, CA$220,670–$259,610 / yearIt continues with our one-of-a-kind management program designed to build the best managers in the industry, where our people managers across functions come together to exchange ideas and grow, as both managers and learners, in an environment that challenges, supports and broadens. What Your Day-To-Day Will Involve: Regulatory representation and leadership to cross-functional products teams, development of regulatory strategies and support PROCEPT's products, marketing applications and post-market activities.
Senior Regulatory Affairs Specialist ProSomnus IncSenior Regulatory Affairs SpecialistPleasanton, CADevelop and implement global regulatory strategies for medical device products (Class I-II as applicable) Prepare, compile, and support FDA regulatory submissions, including 510(k)s, De Novo submissions, Technical Documentation (EU MDR), CE Mark submissions, supplements, and amendments, and international registrations. This role is responsible for developing and executing global regulatory strategies, prepares and manages submissions and registrations, conducts regulatory gap assessments, and supports international market expansion efforts.